Evaluation of FID 114657 on Tear Film Lipid Layer Thickness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848068
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Other: FID 114657 Other: OPTIVE Lubricant Eye Drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
OD (Right Eye)
FID 114657 or OPTIVE
Other: FID 114657
artificial tears

Other: OPTIVE Lubricant Eye Drops
artificial tears

OS (Left eye)
FID 114657 or OPTIVE
Other: FID 114657
artificial tears

Other: OPTIVE Lubricant Eye Drops
artificial tears

Primary Outcome Measures :
  1. lipid layer thickness [ Time Frame: Instill assigned test article to the right eye and begin timing the examination process. Measure lipid layer thickness at 1 minute, 5 minutes, 15 minutes and 60 minutes post instillation ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
  • Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics:

    • Positive response to the question, "Do you ever feel your eyes?";
    • Baseline LLT value of ≤75nm (OU), not varying by more than ±15 nm over the course of a 10-minute observation period, difference in LLT between the two eyes must be ≤15nm, and increase in LLT after three forceful blinks must be ≤15nm.
  • Patients must have best-corrected Snellen visual acuity of 20/70 or better in each eye.
  • Able and willing to follow study instructions.

Exclusion Criteria:

  • Use of topical ocular drops within 12 hours of the study visit; or use of a topical ocular ointment within 36 hours of the study visit. In addition, use of any concomitant topical ocular drugs during the study period.
  • History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • History or evidence of serious ocular trauma in either eye within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • History of and/or current evidence of glaucoma or ocular hypertension in either eye.
  • History of and/or current evidence of active intraocular inflammation in either eye (i.e., retina/macula/choroid).
  • History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Ocular conditions such as active acute blepharitis, conjunctival infections, iritis, conjunctival abnormalities (including pinguecula greater than 1mm in diameter, located closer than 2mm to the limbus or elevated more than 0.2mm), eyelid abnormalities (including entropion and ectropion) or any other ocular condition that may, in the opinion of the investigator, preclude the safe administration of the test articles.
  • Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to the study visit.
  • Any ocular or systemic medical condition that might influence the tear film (other than dry eye).
  • Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued a minimum of 12 hours prior to the study visit.
  • Individuals unwilling to discontinue use of cosmetics (such as eyeliner, mascara or eye shadow) or facial creams on or around the eyelids on the day of the study.
  • Participation in an investigational drug or device study within 30 days of entering this study.

Responsible Party: Alcon Research Identifier: NCT00848068     History of Changes
Other Study ID Numbers: C-07-61
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
lipid layer thickness

Additional relevant MeSH terms:
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions